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The National Cancer Institute Clinical Trials Planning Meeting to Address Gaps in Observational and Intervention Trials for Cancer-Related Cognitive Impairment.
Janelsins, Michelle C; Van Dyk, Kathleen; Hartman, Sheri J; Koll, Thuy T; Cramer, Christina K; Lesser, Glenn J; Barton, Debra L; Mustian, Karen M; Wagner, Lynne I; Ganz, Patricia A; Cole, Peter D; Bakos, Alexis; Root, James C; Hardy, Kristina; Magnuson, Allison; Ferguson, Robert J; McDonald, Brenna C; Saykin, Andrew J; Gonzalez, Brian D; Wefel, Jeffrey S; Morilak, David A; Dahiya, Saurabh; Heijnen, Cobi J; Conley, Yvette P; Morgans, Alicia K; Mabbott, Donald; Monje, Michelle; Rapp, Stephen R; Gondi, Vinai; Bender, Catherine; Embry, Leanne; McCaskill Stevens, Worta; Hopkins, Judith O; St Germain, Diane; Dorsey, Susan G.
Affiliation
  • Janelsins MC; Division of Supportive Care in Cancer, Department of Surgery, University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, NY, USA.
  • Van Dyk K; University of California, Los Angeles, Los Angeles, CA, USA.
  • Hartman SJ; Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, San Diego, CA, USA.
  • Koll TT; Division of Geriatrics, Gerontology and Palliative Medicine, Department of Medicine, University of Nebraska Medical Center, Omaha, NE, USA.
  • Cramer CK; Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
  • Lesser GJ; Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
  • Barton DL; University of Tennessee, Knoxville, College of Nursing, Knoxville, TN, USA.
  • Mustian KM; Division of Supportive Care in Cancer, Department of Surgery, University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, NY, USA.
  • Wagner LI; Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC, USA.
  • Ganz PA; University of California, Los Angeles, Los Angeles, CA, USA.
  • Cole PD; Division of Pediatric Hematology/Oncology, Rutgers Cancer Institute, Princeton, NJ, USA.
  • Bakos A; National Cancer Institute, Bethesda, MD, USA.
  • Root JC; Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Institute, New York, NY, USA.
  • Hardy K; National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
  • Magnuson A; Division of Hematology/Oncology, Department of Medicine, University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, NY, USA.
  • Ferguson RJ; Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
  • McDonald BC; Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
  • Saykin AJ; Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
  • Gonzalez BD; Moffitt Cancer Center, Tampa, FL, USA.
  • Wefel JS; Department of Neuro-Oncology, MD Anderson Cancer Center, Houston, TX, USA.
  • Morilak DA; University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
  • Dahiya S; Stanford Medicine, Palo Alto, CA.
  • Heijnen CJ; Rice University, Houston, TX, USA.
  • Conley YP; University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.
  • Morgans AK; Dana Farber Cancer Institute, Boston, MA, USA.
  • Mabbott D; Hospital for Sick Children, Toronto, ON, CA.
  • Monje M; Stanford Medicine, Palo Alto, CA.
  • Rapp SR; Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
  • Gondi V; Northwestern Medicine, Chicago, IL, USA.
  • Bender C; University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.
  • Embry L; University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
  • McCaskill Stevens W; National Cancer Institute, Bethesda, MD, USA.
  • Hopkins JO; Southeast Clinical Oncology Research Consortium, Winston-Salem, NC, USA.
  • St Germain D; National Cancer Institute, Bethesda, MD, USA.
  • Dorsey SG; University of Maryland, Baltimore, Baltimore, MD, USA.
J Natl Cancer Inst ; 2024 Sep 09.
Article in En | MEDLINE | ID: mdl-39250738
ABSTRACT
Cancer-related cognitive impairment (CRCI) is a broad term encompassing subtle cognitive problems to more severe impairment. CRCI severity is influenced by host, disease, and treatment factors and affects patients prior to, during, and following cancer treatment. The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee (SxQoL SC) convened a Clinical Trial Planning Meeting (CTPM) to review the state of the science on CRCI and to develop both Phase II/III intervention trials aimed at improving cognitive function in cancer survivors with non-central nervous system (CNS) disease and longitudinal studies to understand the trajectory of cognitive impairment and contributing factors. Participants included experts in the field of CRCI, members of the SxQOL SC, patient advocates, representatives from all seven NCI Community Oncology Research Program (NCORP) Research Bases, and the NCI. Presentations focused on the following topics measurement, lessons learned from pediatric and geriatric oncology, biomarker and mechanism endpoints, longitudinal study designs, and pharmacologic and behavioral intervention trials. Panel discussions provided guidance on priority cognitive assessments, considerations for remote assessments, inclusion of relevant biomarkers, and strategies for ensuring broad inclusion criteria. Three CTPM working groups (longitudinal studies and pharmacologic and behavioral intervention trials) convened for one year to discuss and report on top priorities and to design studies. The CTPM experts concluded sufficient data exist to advance Phase II/Phase III trials utilizing selected pharmacologic and behavioral interventions for the treatment of CRCI in the non-CNS setting with recommendations included herein.

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: J Natl Cancer Inst Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Estados Unidos

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: J Natl Cancer Inst Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Estados Unidos